The study employed matched case control study design for clients under ART. For the comparison purpose, non-adherent subjects were matched by age and sex with adherent controls.
The study was conducted in four hospitals found in Tigray Regional state. Tigray regional state which is found in north Ethiopia has an estimated total population of 4,314,456 according to Central Statistical Authority [CSA] report in 2007 [16]. It has five zonal Administrative Divisions and there are about 1.8% PLHIV [2], among these about 28,044 are on ART. Tigray Regional state has 14 hospitals and 219 health centers [17]. The ART patients taking treatment and care in ART clinics of the hospitals included in the study are Mekelle hospital 3645, Adwa hospital 876, St. Marry hospital 942 and Suhul hospital 1098. The study period was from August 5/2012 to October 17/2012.
The study population was adult HIV/AIDS positive subjects greater than 18 years who were in ART follow up in four Hospitals of Tigray regional state. Participants with incomplete data for last three visits and women on ART who were on current pregnancy were excluded from the study. Non-adherent participants from document who were adherent in the current visit, and adherent participants with good adherence from document and who were non-adherent at current visit were also excluded.
The sample size is computed by Kelsey formula for case control studies in OpenEpi Version 3.03.17 assuming a ratio of non-adherent cases to adherent controls of 1:1, a two-sided significance level (alpha) of 0.05, Power 80% and assuming 15% difference in nutritional status between the adherent and non-adherent subjects. In a case control study done in Pwani Region eastern Tanzania, the difference between the two groups in educational status, income, occupation and other socioeconomic factors which also are included in our study is less than 12% [18]. However, considering the cost and the design of the study the 15% difference assumption was taken for calculating the sample size. By considering this the sample size calculated for both groups was 171 pair. With adjustment for non-response (5%), the sample size for both groups’ was 180 pair.
From the governmental hospitals found in the Tigray regional state, four hospitals were selected purposely considering the load and the availability of Fluorescence-Activated Cell Sorting [FACS] Count Machine for CD4 count and CBC (complete blood count) machines for the purpose of getting an adequate number of non-adherent subjects with better documentation within the given shorter period of data collection. By scanning patient ART follow up charts we selected patients who were non-adherent (poor and fair) at least once in the last three visits for follow up appointment. From the selected non-adherent HIV-infected clients, those who reported having ingested less than 95% of the total number of the prescribed antiretroviral medication for the last one month were considered as “cases”. Age and sex matched adherent controls that were with good adherence in all of the last three visits and those who reported having ingested 95% or more of the total number of the prescribed antiretroviral medication for the last one month was considered as “controls”. Finally data was collected for the matched pair by collecting first the non-adherent cases and then the adherent controls for each case (106 from Mekelle hospital, 28 from Suhul hospital, 21 from St. Marry hospital and 19 from Adwa hospital), until the matched sample size make up the whole sample of 174.
The primary dependent variable was Adherence to ART and other independent variables were defined as a categorical variable with the following:-
Adherence to ART: - is defined as taking one’s medicine as prescribed and agreed between the patient and provider which is 95% or more adherence to ART. Which means taking doses no more than two hours before or two hours after the time of a doctor’s advice to take doses (95% or more adherence = missing ≤2 doses of 30 doses or ≤3 doses of 60 doses) [11, 19].
Non-adherence to ART: - is the condition of missing doses completely, not following information given by a physician, as well as taking drugs inappropriately. Which means taking doses two or more hours before, and/or two or more hours after the time of a doctor’s advice to take doses or missing doses completely (less than 95% adherence = missing >2 doses of 30 doses or >3 doses of 60 doses) [11, 19].
PHQ-9 score for depression (points): - A score of 1 to 4 - No depression, 5 to 9 - Mild depression, 10 to 14 - Moderate depression, 15 to 19 - Moderately Severe depression and 20 to 27 - Severe depression [20].
Altitude adjusted hemoglobin:- the adjustment is subtracted from each individual’s observed hemoglobin level to calculate an adjusted hemoglobin. The altitude of Adwa, Shire, Mekelle and Axum is 1882, 1953, 2084 and 2195 meter respectively from sea level which is found in the range 1750≤ m <2250 which will be adjusted by subtracting 0.8 g/dl from the observed hemoglobin [21].
Functional Status: -
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Working actively: Able to perform usual work in or out of the house.
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Ambulatory: Able to perform activities of daily living.
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Bedridden: Not able to perform activities of daily living [22].
In all investigations, the measurement was completed as follows. Height was measured to the nearest 1 centimeter using a portable, free – standing stadiometer. Weight was measured to the nearest 0.01kg using ward or clinical based clinical scales, all of which were calibrated at the start of the study. We were rate good appetite for those study participants who eats full of the plate and/or most of plate and we were rate poor appetite for those study participants who eats half of the plate and less. We have collected data on adequate and/or quality food by using questions of eating pattern and nutritional factors. We were rate adequate for those study participants who get three or more meals per day with and without eating between meals.
Data on demographic factors, nutritional factors, immuno-hematological factors and self report adherence to ART were collected by document review, anthropometric measurements, and by using a structured pre-tested questionnaire which is developed from different literatures. The structured questionnaire was prepared in English version and translated to Tigrigna, and again back to English to confirm the correctness of the translation, efficiency of questionnaire and for analysis purpose. It had detailed questions on predictor factors like socio-demographic characteristics, psychosocial factors, nutritional factors and ART self reported adherence. Interview was conducted to fill the structured questionnaire in their own respective ART clinics after being oriented as to how to do it by trained data collectors and supervisors. The data collectors were 4 case managers, 4 nurses or health officers and 4 MSc students as supervisors.
After coding the data was entered using Excel, data cleanup and cross-checking was done and it was analyzed by using STATA version 10 by principal investigator using conditional logistic regression (clogit) model for matched case control analysis. The association of each variable with non-adherence was tested using the odds ratio, the 95% confidence interval and p value; a p-value less than 0.05 being considered statistically significant.
Ethical clearance was obtained from University of Gondar research and publication office and then the ethical clearance was submitted to Tigray Regional Health Bureau. Official letters given from Tigray Regional Health Bureau was submitted to the respective hospital administration Chief Executive Officers and Medical Directors to get formal permission. The purposes and importance of the study was explained and informed consent was secured from each participant. Confidentiality was maintained at the data collection process and data analysis stages. All of the study participants were assured that the data will be anonymous, names or any personal identifiers will not be recorded and that was done according to the agreement. Participant’s involvement in the study was on voluntary basis and those who wish to quit their participation at any stage were informed to do so without any restriction.